SuperPath® - a pilot study

Department of orthopedic surgery0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•Patient is 18 to 75 years of age, inclusive
•Patient is able to speak and write Dutch
•Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following:
•o Osteoarthritis
•o Avascular necrosis (AVN)
•o Inflammatory arthritis
•o Rheumatoid arthritis with adequate bone quality
•o Post-traumatic arthritis
•o Congenital hip dysplasia.
•Patient has no history of previous total hip replacement or arthrodesis of the affected hip
•Patient is willing and able to provide written informed consent.

•Subjects will be excluded when they meet one or more of the following contra-indications for the SuperPath® technique:
•Infection, sepsis, and osteomyelitis
•Patients with a low femoral offset
•Uncooperative patient or patient with neurologic disorders who are incapable of following directions
•Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
•Metabolic disorders which may impair bone formation
•Osteomalacia
•Distant foci of infections which may spread to the implant site
•Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
•Vascular insufficiency, muscular atrophy, neuromuscular disease
•Additionally, subjects will be excluded when they meet the following exlusion criteria:
•Patients with emergency or semi-emergency THA (e.g. for treatment of femoral neck fractures)
•Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
•Revision THA surgery of the ipsilateral side
•Contralateral THA <6 months before current surgery

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